ARTHRO-KNIFE, 2-SIDE POINT

Description of Event or Problem

THE CUSTOMER REPORTED THAT DURING PRE-OPERATIVE TESTING, WHEN THE ARTHRO-KNIFE BLADE WAS RETRACTED, IT WOULD NOT FULLY RETURN INTO THE SHEATH.

Additional Manufacturer Narrative

INVESTIGATION RESULTS: AN INVESTIGATION CONFIRMED THE REPORTED PROBLEM. UPON TESTING OF THE RETURNED UNIT, APPROXIMATELY 1 MM OF THE BLADE DID NOT RETRACT INTO THE SHEATH. DISASSEMBLY FOUND THE LOOP PORTION BROKEN AT THE TRIGGER. CONMED LINVATEC HAS INITIATED A CORRECTIVE ACTION TO ADDRESS THIS FAILURE MODE. THE INSTRUCTIONS FOR USE (IFU) INFORMS THE USER: INSPECT THE KNIFE ASSEMBLY, INCLUDING THE RETRACTABLE SLIDE, FOR DAMAGE (E.G., CRACKS, DENTS) PRIOR TO USE. DO NOT USE IF BLADE DOES NOT FULLY RETRACT. DO NOT USE IF ANY DAMAGE IS NOTICED. PRIOR TO WITHDRAWAL FROM THE SURGICAL SITE, VISUALIZE THE BLADE TIP TO BE SURE IT IS FULLY RETRACTED WITHIN THE SHEATH. INJURY MAY RESULT. SHEATHED ARTHROSCOPY KNIFE BLADE CUTTING SURFACES ARE VERY SHARP. DO NOT INSERT OR REMOVE INSTRUMENT FROM PATIENT WHEN THE BLADE IS EXTENDED OUT OF THE SHEATH. ALWAYS RETRACT THE BLADE WITHIN THE SHEATH PRIOR TO INSERTION OR REMOVAL OF THE INSTRUMENT FROM THE PATIENT. INJURY MAY RESULT.